MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAV 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734239

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, mnav product quality experience received three voluntary medwatch reports (mw5038651, mw5038652, and mw5038653), as part of an additional information request letter from the fda.A review of the medwatch reports identified 2 individual user incidents and 6 devices with no information regarding a site location, contact representative, details of any treatment required, or any device lot numbers.All three medwatch reports contained the following event description: "while cleaning instruments two different employees incurred needle-sticks on two different occasions.Both employees experienced the same issues.While cleaning neuro instrumentation.Bone was stuck in the very narrow long channel.The channel is approx 14 inches long and the channel size is about the size of a 23 gauge needle.The instrument was soaked and placed in the ultrasonic washer several times.When the bone did not come out, the cleaning rod was used to push the debris out of the channel.The bone was very hard and while pushing the thin rod through the chanel, the rod punctured the employees skin.There are two issues with these products.The long narrow channel is difficult to clean.Bone is stuck within the channel making it extremely difficult to clean.A cleaning rod is provided to clean the channel, not a brush.The rod may be scratching the channel, making hiding places for bacteria.The narrow design of the channel has resulted in employee needle-sticks.The third concern is that these devices require a 10 extended steam sterilization cycle.These taps are mfg as medtronic o-arm instrumentation with the following product numbers: 9734239, 5.5mm tap; 9734240, 6.5mm tap; 9734238, 4.5mm tap; 9734302, 6.5mm tap; 9734300, 5.5mm tap; 9734298, 4.5mm tap." as clarification, this is one of 3 individual mdrs (1723170-2014-01313, 1723170-2014-01314, and 1723170-2014-01315) being submitted to the fda corresponding to the three voluntary medwatch reports (mw5038651, mw5038652, and mw5038653) received.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No details of the alleged user injury, or the treatment required, were made available.The individual described as having received an injury, was a site representative user of the device.This user injured him/herself while cleaning/sterilizing the instrument.Device lot number was not provided on the medwatch report.The initial reporter did not generate a report to the fda, but as an fda representative, received the original report via medwatch, and forwarded that report to medtronic navigation, inc.The mdr has been marked serious injury, based solely on the medwatch report allegation of a "needle stick" to the user.No further details were provided.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.(b)(4) 2014 - a fda representative confirmed via e-mail communication, that there was no further information regarding the location of the site, contact information, or lot numbers of the devices reported on the medwatch reports.The following investigation came from the response to an additional information request letter to the fda being submitted concurrently with this mdr: the voluntary medwatch reports were not submitted by medtronic navigation, inc.(mnav), and the complaint was not reported directly to mnav.A review of the complaint history found no similar complaints reported during the timeframe that correlated to the medwatch reports.These medwatch reports have been documented in the mnav complaint database and were processed per procedure.Follow-up regarding the devices and/or site contact information, at this time, is not possible due to the limited details provided on the medwatch reports (no location or facility information was included).Since the devices have not been returned to the manufacturer for analysis, a definitive conclusion could not be reached.Based on engineering analysis of a previously opened capa investigation, the following root causes were identified: cannulated taps were being used in open (as opposed to minimally invasive) spine procedures without the use of a guide wire causing the taps to become occluded.The instructions for use (ifu) did not provide information concerning the potential cleaning difficulty associated with the use of cannulated taps without the use of a guide wire, and ways to mitigate this cleaning difficulty.A risk assessment conducted in association with the existing capa evaluated risk to both the user and the patient.The risk to user and patient safety remains acceptable.The medwatch reports contained three additional device allegations which are addressed below: "a cleaning rod is provided to clean the channel, not a brush." mnav does not supply or sell a rod or brush for the purpose of cleaning the device."the narrow design of the channel has resulted in employee needle-sticks." cannula sizes are based on the industry sizes of guide wires used with the device.Mnav also sells non-cannulated versions of these devices for open spine procedures without the use of a guide wire.".These devices require a 10 extended steam sterilization cycle." the ifu that accompanies the devices contains no such requirement.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: NAV 5.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 4327330
• MDR Text Key: 16851104
• Report Number: 1723170-2014-01314
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,company representative,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other